BioSig Completes Enrollment in the PURE EP 2.0 Clinical Study
BioSig Technologies, Inc. (BSGM) has completed enrollment for its PURE EP 2.0 clinical trial, involving 51 patients across multiple prestigious hospitals, including Mayo Clinic and Massachusetts General Hospital. The trial aims to validate the effectiveness of the PURE EP System against traditional cardiac signal sources. BioSig anticipates announcing results in Q3 2021, with further insights expected at the Heart Rhythm 2021 convention in late July. The PURE EP System, already FDA cleared, is designed to enhance signal fidelity, potentially leading to improved procedure efficacy and reduced healthcare costs.
- Completed enrollment of 51 patients in the PURE EP 2.0 clinical trial at leading hospitals.
- The PURE EP System has FDA 510(k) clearance and commenced commercialization in 2020.
- Clinical data from the trial can support a national rollout of the technology in the U.S.
- The announcement of results is not expected until Q3 2021, which may delay market impact.
Westport, CT, April 13, 2021 (GLOBE NEWSWIRE) --
- 51 patients undergoing elective cardiac ablation treatments were enrolled in the trial at Mayo Clinic, Massachusetts General Hospital, and St. David’s Medical Center
- The trial is designed to demonstrate the quality and clinical value of the PURE EPTM signals when compared to conventional sources of cardiac signals. The Company expects to announce the study results in Q3 2021
BioSig Technologies, Inc. (NASDAQ: BSGM) (“BioSig” or the “Company”), a medical technology company commercializing an innovative signal processing platform designed to improve signal fidelity and uncover the full range of ECG and intra-cardiac signals, today announced it completed enrollment in the PURE EP 2.0 clinical trial.
The multi-center, prospective clinical trial was conducted at the Texas Cardiac Arrhythmia Institute at St. David’s Medical Center in Austin, TX, Mayo Clinic Florida Campus in Jacksonville, FL, and Massachusetts General Hospital in Boston, MA. During the trial, the PURE EPTM System was used in all types of arrhythmia cases, including atrial fibrillation, ventricular tachycardia, and atrial flutter. Atrial fibrillation, the most common arrhythmia type affecting over 6 million people in the U.S.1, accounted for over
The PURE EPTM System has been awarded FDA 510(k) clearance. The Company commenced commercialization in 2020, having recently announced commercial sales to St. David’s HealthCare of Austin, Texas, an HCA Healthcare-owned hospital, and Mayo Foundation for Medical Education and Research. Clinical data, collected under the terms of the PURE EP 2.0 study, will support the national rollout to medical centers across the U.S.
The study aimed to establish the safe and effective use of the PURE EPTM System and assess the quality of the PURE EPTM intracardiac signals when compared to existing recording and mapping systems. Collected clinical data underwent randomized, blinded, controlled evaluation by a panel of independent electrophysiologists to determine the clinical value of the PURE EPTM signals. The Company has submitted a scientific abstract for consideration by the Heart Rhythm Society. It expects to announce the study results at the Heart Rhythm 2021 convention, which is due to take place on July 28-31, 2021. The Company expects to publish the full clinical study results in leading industry publications in the second half of 2021.
In Q3 2020, the Company announced the data results recorded during 15 atrial fibrillation ablation procedures from the PURE EPTM System, the signal recording system, and the 3D mapping system. The review concluded that the PURE EPTM signals were preferred to conventional sources of intracardiac signals.
In addition to the enrolled patient data, the Company maintains a registry of over 600 ablation procedures performed with the PURE EPTM System at eight hospitals in the United States. This dataset is being used to support new product development to complement the PURE EPTM System.
"We are pleased to complete the enrollment in our flagship clinical study. The objective of our clinical strategy is to determine the clinical and economic benefits of the PURE EPTM System which could include improved procedure efficacy, reduced procedure times, and a decrease in repeat procedures,” commented Kenneth L. Londoner, Chairman and CEO of BioSig Technologies, Inc. “Strong clinical evidence is the foundation of our commercial strategy. We look forward to revealing the clinical findings from our trial in the coming months and engaging the healthcare community in our new, targeted studies to demonstrate the additional clinical value of our technology.”
About BioSig Technologies
BioSig Technologies is a medical technology company commercializing a proprietary biomedical signal processing platform designed to improve signal fidelity and uncover the full range of ECG and intra-cardiac signals (www.biosig.com).
The Company’s first product, PURE EPTM System is a computerized system intended for acquiring, digitizing, amplifying, filtering, measuring and calculating, displaying, recording, and storing of electrocardiographic and intracardiac signals for patients undergoing electrophysiology (EP) procedures in an EP laboratory.
Forward-looking Statements
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1 Top 10 Things You should Know About Heart Rhythm; Scripps Health.
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